Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Associate Director Global Regulatory Affairs Biotech CMC
Your tasks and responsibilities
The primary responsibilities of this role, Associate Director Global Regulatory Affairs Biotech Chemistry Manufacturing and Controls (CMC), are to:
* Represent global Regulatory Affairs (RA) CMC in various cross-functional teams, including CMC development teams, product supply teams, global regulatory teams;
* Be responsible for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products and product portfolio in close cooperation with the relevant global, regional, and country RA functions, Bayer Product Supply, Quality, Medical, and Marketing to ensure early identification of major regulatory hurdles and issues;
* Provide active input into Global Regulatory Teams for assigned projects to ensure timely submission and first cycle approval;
* Be responsible for timely availability and final CMC content of Investigative New Drug/Investigational Medicinal Product Dossier (IND/IMPD), Biologics License Applications/ Marketing Authorization Applications (BLA/MAA)-, or supplemental submissions for assigned products and product portfolio to Health Authorities, including responses to health authority questions;
* Be responsible for CMC change management evaluation for assigned development and marketed products;
* Compile variation packages and coordination of responses to health authority questions;
* Collaboration with CMC Managers, Senior Managers, and Specialists to ensure close alignment of CMC activities across the Therapeutic Area groups;
* Propose and implement standards concerning CMC documentation in close co-operation with global, regional, and local RA functions, and Bayer Product Supply;
* Achieve assigned global regulatory affairs project objectives for assigned products and product portfolio using effective oral, written, and presentation skills;
* Have the ability to deal with critical and/or sensitive issues with internal and external customer group;
* Ensure adequate surveillance of the CMC related regulatory environment, particularly for assigned biotechnology pharmaceutical products, and anticipates and influences changes in this environment globally.
Domestic Relocation Assistance is available
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
* Ph.D., Pharm D, or equivalent scientific degree with at least 8 years pharmaceutical industry experience, including 3 years of relevant RA experience OR M.S. degree in life sciences with at least 10 years' pharmaceutical industry experience OR B.S. degree in life sciences with at least 12 years' pharmaceutical industry experience, which includes at least 7 years' of relevant RA experience.;
* Fluent in English;
* Excellent oral and written communication skills;
* Ability to work within a global team framework and a multi-cultural environment;
* Must work directly with different hierarchical levels within Bayer;
* Ability to establish relationships between individual departments;
* Must be able to absorb large amounts of information efficiently and give sound judgements to manage difficult situations effectively;
* Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure;
* Must have good knowledge of the pharmaceutical industry, general business practices and processes;
* Good problem-solving skills as applicable to drug regulatory issues;
* Strong analytical skills and well developed project management skills;
* Scientific and technical expertise, including the ability to develop/execute robust regulatory strategies, timelines and action plans.
* Experience with development biotechnology functions;
* Knowledge of other languages (i.e. German);
* RA experience with biotech products/devices, including but not limited to antibody drug conjugate development (ADC);
* Knowledge of gene therapy development;
* Experience in dealing with Drug Regulatory Bodies.
* Knowledge of drug regulations and guidance documents on drug development and license variations in International Harmonization Committee (ICH) countries;
* Knowledge of regulatory expectations in non-ICH regions.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Country: United States
Career Level Student Entry Level Professional
Associated topics: bioinformatic, biological engineer, biomedical engineer, bioprocessing, fermentation, genetic, metabolic, neuroscience, parenteral, therapeutic